The medical industry is rapidly adopting new technology that enables better communication and performance of products & systems to improve the safety of care. Manufacturers today, face a number of compliance challenges, as devices that do not meet the highest quality and safety standards present, a risk of injury, recalls, bans and liability.

IEC 60601-1-2 4th Edition introduced significant technical revisions such as risk management, risk analysis and changes to immunity requirements. These significant changes include specification of immunity test levels according to the environments of intended use, which are categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments. It is imperative for everyone involved with product design to fully understand how the process of risk management and risk analysis incorporates with new requirements to achieve compliance.

Why to attendAt a glance

In this Medical EMC Webinar, you'll get an in-depth overview of IEC 60601-1-2 4th Edition with critical insights into emissions and immunity aspects of medical product design, the revamped classification system based on the environments of intended use, and risk management from MET's EMC testing Experts including:

About MET Laboratories

MET Laboratories is an internationally-recognized resource for regulatory certification of electrical products for the worldwide marketplace. Testing covers a wide range of regulatory, commercial and military standards. MET Laboratories is headquartered in Baltimore, Maryland, with office locations in Union City and Santa Clara, California, Austin, Texas, Cary, North Carolina, and wholly-owned international locations in Shenzhen, China; Taipei, Taiwan; Seoul, Korea; and Milan, Italy.

MET Laboratories certifies or tests medical electrical equipment for Product safety compliance in the United States and Canada, EMC compliance, FDA Guidance Documents and consensus standards necessary for FDA clearance, including IEC 60601, AAMI and ASTM standards, Electrical wheelchairs to the ANSI/RESNA/FDA and European EN 12184 requirements.
MET is the first NRTL licensed by OSHA for medical equipment. OSHA regulations cover all workplaces, which include hospitals, clinics, therapy centers, and similar facilities. MET-certified medical products have been universally accepted in the US and Canada.